Cleared Abbreviated

K081060 - FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5

K081060 is an FDA 510(k) clearance for FERROFIBRE STAINLESS STEEL SUTURES, manufactured by Core Essence Orthopaedics, LLC. The device is a Class 2 General & Plastic Surgery device with product code GAQ cleared through the Abbreviated 510(k) pathway after a 254-day FDA review.

K081060 · Core Essence Orthopaedics, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
254d
Days
Class 2
Risk

K081060 is an FDA 510(k) clearance for the FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5. Classified as Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (product code GAQ), Class II - Special Controls.

Submitted by Core Essence Orthopaedics, LLC (Yardley, US). The FDA issued a Cleared decision on December 24, 2008 after a review of 254 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4495 - the FDA general and plastic surgery device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Core Essence Orthopaedics, LLC devices

FDA 510(k) Submission Details - K081060

510(k) Number K081060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2008
Decision Date December 24, 2008
Days to Decision 254 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 115d · This submission: 254d
Pathway characteristics
Standards-based clearance path.

GAQ Device Classification - Class 2, Special Controls

Product Code GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4495
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

All 20
Devices cleared under the same product code (GAQ) and FDA review panel - the closest regulatory comparables to K081060.
Surgical Stainless Steel Suture, Stainless Steel Suture
K170767 · Ethicon, Inc. · Nov 2017
DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
K141007 · Demetech Corp. · Sep 2014
FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
K140127 · Pontis Orthopaedics, LLC · May 2014
SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17
K063603 · Suturtek Incorporated · Feb 2007
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SYNTHES (USA) TITANIUM WIRE
K041333 · Synthes (Usa) · Aug 2004